A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02227732|
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : August 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusions||Device: New Indwelling Pleural Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
|New Indwelling Pleural Catheter||
Device: New Indwelling Pleural Catheter
Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
- Device -related safety and the number of adverse events. [ Time Frame: 28 days post catheter insertion ]
- pleurodesis success [ Time Frame: 14 days ]Assessed by chest x-ray, thorachic ultrasound, and confirmation the catheter is patent.
- Pleurodesis success [ Time Frame: 28 days ]Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
- pleurodesis success [ Time Frame: 60 days ]Assessed by chest x-ray, thoracic ultrasound and confirmaiton the catheter is patent.
- Breathlesness [ Time Frame: 14, 28, 60 days ]
- Chest Pain [ Time Frame: 14, 28, 60 days ]
- Time to pleurodesis [ Time Frame: 14, 28, 60 days ]
- Quality of Life [ Time Frame: 14, 28, 60 days ]
- Need for further pleural intervention post catheter removal [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227732
|Southmead Hospital - Academic Resporatory Unit|
|Westbury on Severn, Bristol, United Kingdom, BS10 5NB|